Health Canada Issues Notice on Use of FDA Guidance Material to Support Canadian Medical Devices License Applications

On August 4, 2016, Health Canada issued a notice entitled “Use of United States Food and Drug Administration (FDA) Guidance Materials to support Canadian Medical Devices License Applications” (the Notice). According to the Notice, Health Canada encourages manufacturers to use FDA guidance materials to address premarket submission requirements for medical devices where no similar Health Canada guidance documents are available.

The Notice is part of the Medical Device Single Audit Program (MDSAP), under which Health Canada and the FDA have been working to converge the medical devices regulatory compliance in the two countries. The MDSAP is a three year pilot program that began in January 2014.

Summary By: Meenakshi Lakhanpal